Babies may soon get protection from Respiratory Syncytial Virus, also known as RSV.
The Food and Drug Administration has accepted an application from Pfizer to review its RSV vaccine for pregnant individuals.
“If approved, RSVpreF would help protect infants at their first breath from the devastating effects of this infectious disease, which though well-known, has been particularly evident throughout this RSV season,” said Annaliesa Anderson, chief scientific officer of vaccine research and development for Pfizer.
Pfizer says a large international study found vaccinating moms-to-be was nearly 82% effective at preventing severe cases of RSV in their babies’ most vulnerable first 90 days of life. At age 6 months, the vaccine still was proving 69% effective against serious illness — and there were no signs of safety problems in mothers or babies.
There is currently no vaccine to prevent RSV, which can be serious and even life-threatening for very young children.
In the U.S., about 58,000 children younger than 5 are hospitalized for RSV each year and several hundred die from the virus.
The FDA is expected to make a determination by August. If approved, this would be the first vaccine for pregnant individuals to protect against RSV.